FDA Inspection 1086640 — CURALLUX LLC
The FDA completed an inspection of CURALLUX LLC on April 17, 2019 in Doral, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 17, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5005 | 21 CFR 1002.11 | Failure to submit |
| 5031 | 21 CFR 1010.2(a) | Lack of certification of conformance |
| 5044 | 21 CFR 1010.3(a)(2) | ID label lacks place, month & year of manufacture |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |